Substrate Solution
by Shenzhen Cinnaray Life Technology Co., Ltd. 19 variants
Ref B020130mLModel Architect-1, Architect-2, Alinity-1, Alinity-2, IM10, IM 11, BKM, XCY1, XCY2, AT-A, AT-B, MR, YHL-2, YHL-3, QS-A, QS-B, WG-A, WG-B
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number698002989DWYTQ 06980029891237 | Date31 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Substrate Solution
- Model / Reference
- Architect-1, Architect-2, Alinity-1, Alinity-2, IM10, IM 11, BKM, XCY1, XCY2, AT-A, AT-B, MR, YHL-2, YHL-3, QS-A, QS-B, WG-A, WG-B, B020130mL
- Primary DI / UDI-DI
- 06980029891237
- Basic UDI-DI
- 698002989DWYTQ
- EMDN Code
- W0103010199 Reagents for (automated) haematology analyzer - other
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000057751
- Authorised representative
- HUMISS TRADING S. L. ES-AR-000040177
Other devices from Shenzhen Cinnaray Life Technology Co., Ltd.
See all devices from Shenzhen Cinnaray Life Technology Co., Ltd. →
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No